BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2830320 · Received November 13, 2012

    Report

    Report Number
    1644487-2012-02984
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 2, 2020
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORT THAT HE PATIENT HAD AN INCREASE IN SEIZURES BETWEEN (B)(6) 2011. THERE WAS MENTION IN CLINIC NOTES THAT THE PATIENT'S SEIZURES WERE WORSE WITH THE SUMMER HEAT AND THE MOM GOT AIR CONDITIONING FOR THE PATIENT'S ROOM. IT IS UNCLEAR IF THE INCREASE IN SEIZURES ARE RELATED TO VNS. PREVIOUS ATTEMPTS WITH THE PHYSICIAN ON ANOTHER MATTER RELATING TO THIS PATIENT WERE UNSUCCESSFUL AS HE DECLINE TO PROVIDE INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    SUPPLEMENTAL #2 PREVIOUSLY REPORTED UNDER MFR REPORT #:1644487-2018-00565. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY IN 2012. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201114

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR